CMS has posted the Medicare Part B drug and biological average sales price (ASP) amounts for January 1 to March 31, 2009. According to CMS, average payment amounts for all drugs increased 1% compared to the last quarter of 2008.
On December 10, 2008, CMS provided further guidance on accreditation requirements for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) under the Medicare for Patients and Providers Act of 2008 (MIPPA). MIPPA exempts certain eligible professionals from the general September 30, 2009 accreditation deadline if unless CMS determines that the quality standards are specifically designed to apply to such professionals and persons. The eligible professionals to whom this exemption applies include physicians, physical therapists, occupational therapists, qualified speech-language pathologists, physician assistants, and nurse practitioners. Also as authorized by MIPPA, CMS has specified that certain “other persons” – specifically orthotists, prosthetists, opticians, and audiologists – are exempt from the general accreditation requirements. CMS will issue rules in 2009 on how the quality standards apply to these eligible professionals and other persons. CMS also has clarified that individuals not included in this exemption list, such as pedorthotists, mastectomy fitters, orthopaedic fitters/ technicians or athletic trainers applying for Medicare enrollment in order to bill for Medicare Part B services are not exempt from meeting the September 30, 2009 deadline for DMEPOS accreditation.
CMS has provided additional guidance on a provision of the November 19, 2008 final Medicare physician fee schedule rule for calendar year 2009. In the final rule, CMS adopted a requirement that an entity providing mobile diagnostic testing services enroll with Medicare as an Independent Diagnostic Testing Facility (IDTF), comply with the IDTF performance standards, and bill Medicare directly for its services (although CMS did not require a mobile testing entity to bill directly for its services they are furnished “under arrangement” to hospitals). In a frequently-asked question dated December 15, 2008, CMS clarifies that if the mobile provider of testing services provides only the equipment and the non-physician technicians, they are not required to enroll and bill as an IDTF. Note, however, that if the mobile provider also provides the physician supervision of the test as well as the equipment and the technician, the mobile entity would be required to enroll and bill as an IDTF effective January 1, 2009.
CMS has released the detailed specifications for the 2009 Physician Quality Reporting Initiative (PQRI) measures and the 2009 PQRI measures groups. In addition, a new 2009 PQRI Implementation Guide instructs physicians on how to implement 2009 PQRI claims-based reporting of measures to facilitate satisfactory reporting of quality data codes.
On December 18, 2008, CMS posted quality ratings for the nation’s Medicare- and Medicaid-participating nursing homes on the CMS Nursing Home Compare Web site. Each facility has been assigned a “star rating” based on health inspection results, quality measures, and staffing levels. CMS acknowledges certain limits to its rating system, including, among other things, state variations in inspection and licensing requirements, the fact that the staffing levels represent just a “snap-shot in time,” and lack of adjustments in quality measures for differences in nursing home patient populations. CMS recommends that the nursing home quality rating system be used with other sources of information.
CMS has awarded contracts to review the medical necessity of long term care hospital (LTCHs) stays, as authorized by the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA). Specifically, CMS has awarded contracts to AdvanceMed to perform LTCH sampling and validation, and to Wisconsin Physician Services (WPS) to perform medical review of LTCH claims to determine a national error rate for LTCHs. WPS will use existing inpatient hospital review criteria in order to determine the medical necessity of admission. CMS expects the medical reviews, which are scheduled to begin in January 2009, to help contractors to recover overpayments and determine if additional review is necessary.
Applications for new or revised Healthcare Common Procedure Coding System (HCPCS) codes for the 2010 update are due January 5, 2009.
As previously reported, CMS announced in September that the 2009 Medicare Part B drug competitive acquisition program (CAP) is being postponed indefinitely. The CAP is a voluntary program that offers physicians the option to acquire many injectable and infused Part B drugs from an approved CAP vendor, rather than buying and billing the drugs directly. In preparation for the 2009 CAP postponement, CMS has provided information to physicians on claims submission deadlines for drugs administered in 2008, the procedures for dealing with CAP drugs not administered by December 31, 2008, and emergency restocking of CAP drugs for dates of service on or before December 31, 2008.
On December 2, 2008, CMS proposed three national coverage determinations (NCDs) to deny Medicare coverage of certain types of serious, preventable surgical errors. Specifically, under the proposed NCDs, Medicare would not cover: (1) wrong surgical or other invasive procedures performed on a patient; (2) surgical or other invasive procedures performed on the wrong body part; or (3) surgical or other invasive procedures performed on the wrong patient. The coverage policy is intended to complement CMS’s hospital-acquired conditions policy, under which Medicare will not make higher payments to hospitals for care associated with certain reasonably-preventable conditions unless the condition were reported as present on admission. CMS will accept comments on the proposed coverage policies until January 1, 2009.
CMS has released an “Issues Paper” as part of it’s plan to transition to a Medicare value-based purchasing program for physician and other professional services, as required by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).
CMS has released the 2009 Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fee schedule. The update reflects payment changes mandated by the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008. Specifically, MIPPA reduces the nationwide fee schedule amount of most items included in Round 1 of the DMEPOS competitive bidding program by 9.5% for 2009 (six oxygen codes included in Round 1 will receive a 0% update rather than the 9.5% reduction). Non-competitive bid items will receive a 5.0% update for 2009.
CMS (through The Lewin Group and its subcontractors) is developing a preliminary set of outpatient imaging efficiency measures. CMS is soliciting comments on these measures until December 14, 2008.
On November 17, 2008, CMS reported that the improper payment rate for the Medicare, Medicaid and SCHIP programs fell from 3.9% in FY 2007 to 3.6% percent in FY 2008. For the Medicare fee-for-service program, most improper payments were due to claims for services that were medically unnecessary or incorrectly coded, while the vast majority of Medicaid and SCHIP errors are due to inadequate documentation. CMS also reported the Medicare Advantage improper payment rate for the first time; that rate was 10.6% in 2006, primarily reflecting health plan errors in documenting members’ diagnoses. CMS also is developing methodologies to report the Medicare Part D error rate in the future.
CMS has released a document entitled “Medicare’s Practical Guide to the E-Prescribing Incentive Program,” which explains the e-prescribing incentive program, how eligible professionals can participate, and how to choose a qualified e-prescribing system.
On November 14, 2008, CMS issued a letter to state Medicaid directors to gauge interest in the upcoming “Medicare Nursing Home Value-Based Purchasing" demonstration. The three-year “pay-for-performance” initiative seeks to assess the quality of care in nursing homes, based on selected measures of quality, and then make additional payments to those nursing homes with higher quality performance. States interested in hosting the demonstration are asked to provide certain information to CMS by January 9, 2009. CMS expects to select up to five demonstration states in February 2009, and then CMS will solicit nursing homes within those states to participate in the demonstration.
On November 13, 2008, CMS announced the 15 chronic conditions certain Medicare Advantage special needs plans (SNPs) must use to identify the beneficiary populations eligible for enrollment, beginning in 2010. SNPs are a type of MA plan that serve only beneficiaries living in institutions, eligible for both Medicare and Medicaid, or living with severe or disabling chronic conditions. For SNP purposes, chronic conditions are defined as being medically complex, substantially disabling or life threatening, having a high risk of hospitalization or other adverse outcomes, and requiring a specialized delivery system across domains of care. The specific clinical conditions identified as meeting this definition are: chronic alcohol and other drug dependence; certain autoimmune disorders; cancer excluding pre-cancer conditions; certain cardiovascular disorders; chronic heart failure; dementia; diabetes mellitus; end-stage liver disease; end-stage renal disease requiring dialysis (all modes of dialysis); certain severe hematologic disorders; HIV/AIDS; certain chronic lung disorders; certain chronic and disabling mental health conditions; certain neurologic disorders; and stroke.
CMS has released the 2009 update of the Healthcare Common Procedure Coding System (HCPCS) code set.
On October 28, 2008, CMS informed state health officials of CMS policy regarding the refunding of the federal share of Medicaid overpayments, damages, fines, penalties, and any other component of a legal judgment or settlement when a state recovers pursuant to legal action under its state False Claims Act (FCA). CMS notes that many states have enacted their own FCA statutes modeled on the Federal False Claims Act, and numerous questions have arisen regarding Medicaid overpayment identification, investigation, and refunds of the federal share when that overpayment is attributable to fraud and abuse. Additionally, the letter explains what amounts must be returned to the federal government on any recovery, the proper accounting of the relator’s share and litigation expenses, and the time frame for refunding the federal share of any state FCA recovery.
The Secretary of the Department of Health and Human Services (HHS) has submitted to Congress the Department's annual report on Medicare national coverage determinations (NCDs). The report includes detailed information on the time periods necessary for HHS to complete and implement Medicare NCDs and other background information.
On October 24, 2008, CMS issued a transmittal updating the Medicare Benefit Policy Manual to recognize the four authoritative compendia for use in the determination of a medically-accepted indication of drugs and biologicals used off-label in an anti-cancer chemotherapeutic regimen. The transmittal also modifies requirements for contractors to identify off-label uses that are supported by clinical research.
CMS has released updated final quality standards for Medicare suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The new version, dated October 2008, includes a number of changes from the August 14, 2006 version, including: requirements that the supplier furnish appropriate quality equipment and services; expanded documentation requirements; additional protections related to infection control; protections against adulterated and counterfeit equipment; and a variety of revisions to the product-specific quality standards. Also with regard to suppliers, CMS is seeking final regulatory clearance from the White House Office of Management and Budget for its final Medicare DMEPOS supplier standard and security bond requirements. The text of the rules is not available at this time, but they could be published in the Federal Register in the near future.
CMS has posted guidance for Medicare Part D prescription drug plan sponsors on compliance with its September 18, 2008 final rules updating Part D marketing regulations in conformance with the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).
Medicaid spending is projected to total $339 billion in 2008, up 7.3% from 2007 levels, according to figures released by CMS October 17, 2008. Medicaid spending is expected to continue increasing by 7.9% on average over the next 10 years, reaching $674 billion by 2017, far exceeding the 4.8% projected growth rate for the general economy and pointing to continued strains on state budgets in the coming years. Additional spending details are contained in the CMS Office of the Actuary’s first annual fiscal report on Medicaid.
On October 10, 2008, CMS released details on the scoring methodology it uses to identify those nursing homes that become candidates for the “Special Focus Facility” (SFF) initiative by virtue of their more serious history of severe and persistent quality of care problems.
CMS is soliciting comments regarding an interim study of options for revising geographic location adjustments under the Medicare physician fee schedule, entitled “Review of Alternative GPCI Payment Locality Structures.” CMS notes that it is not proposing to make any changes to the payment localities at this time, but CMS encourages comments on the options presented in the report as well as suggestions for other options, which will be considered in the development of possible future rulemaking on this issue. Electronic comments on the interim report may be submitted to MPFS@cms.hhs.gov until November 3, 2008.
On October 10, 2008, CMS announced that beneficiaries may now review specific Medicare Part D prescription drug plan and Medicare Advantage health plan information for 2009 online through the Medicare Prescription Drug Plan Finder and Medicare Options Compare.
CMS has released most of its “Medically Unlikely Edits” (MUE), which are used by Medicare contractors when processing claims to ensure that providers and suppliers do not report excessive services. An MUE for a HCPCS/CPT code is the maximum units of service under most circumstances that a provider would report for a code for a single beneficiary on a single date of service; claims with more than the MUE edit amount will be denied (unless a modifier is used to used to report medically necessary units of service in excess of an MUE value). The MUE currently contains edits for about 9,700 HCPCS/CPT codes, although CMS is not publishing all active MUEs since it could diminish the effectiveness of MUE edits that are designed to detect and deter questionable payments rather than billing errors. CMS will update the list quarterly.
CMS has announced Medicare Part A and Part B premium and deductible levels for 2009. Notably, there will be no increase in the standard Medicare Part B monthly premium for 2009, which is the first year since 2000 that there was no increase in the standard premium.
CMS has announced the 2009 Medicare PDP and MA plan options. Details about the specific plans in each region will be available mid-October 2008. Open enrollment for 2009 prescription drug coverage begins November 15, 2008 and ends December 31, 2008.
CMS has posted its preliminary payment determinations for certain new clinical laboratory codes. CMS is accepting comments on the payment determinations until October 10, 2008. Separately, CMS has released the October 2008 Medicare Part B prescription drug average sales price (ASP) pricing files.
On September 10, 2008, CMS announced that the 2009 Medicare Part B drug competitive acquisition program (CAP) is being postponed indefinitely. The CAP is a voluntary program that offers physicians the option to acquire many injectable and infused Part B drugs from an approved CAP vendor, rather than buying and billing the drugs directly. While CMS notes that it received several qualified bids for the 2009-11 CAP, "contractual issues with the successful bidders resulted in CMS postponing the 2009 program." The physician election for 2009 CAP participation therefore will not be held, and CAP drugs will not be available from an approved CAP vendor for dates of service after December 31, 2008. CMS is considering implementing change to the CAP before proceeding with another bid solicitation.
The Centers for Medicare & Medicaid Services (CMS) has posted a fact sheet on the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) accreditation provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), including the provisions related to exemption of certain providers from the accreditation requirements. MIPPA section 154(b) exempts certain professionals from the accreditation requirement unless CMS determines the quality standards are specifically designed to apply to such professionals. Under this provision, CMS is exempting the following professionals: physicians; physical therapists; occupational therapists; qualified speech-language pathologists; physician assistants; nurse practitioners; clinical nurse specialists; certified registered nurse anesthetists; certified nurse-midwives; clinical social workers; clinical psychologists; registered dietitians; nutritional professionals; orthotists; prosthetists; opticians; and audiologists. In addition, MIPPA mandates that all existing non-exempt DMEPOS suppliers be accredited as meeting DMEPOS quality standards by September 30, 2009 (new suppliers have been required to be accredited before applying for enrollment since March 1, 2008). To ensure time for accreditation organizations to process the applications, CMS is directing suppliers to submit a complete accreditation application to an approved accreditation organization by January 31, 2009. On October 14, 2008, CMS is hosting an on-site conference at CMS headquarters in Baltimore for non-accredited DMEPOS suppliers to provide technical guidance on how to comply with the DMEPOS quality standards. In a related development, CMS announced on a September 3, 2008 Open Door Forum that it intends to issue a proposed rule next year establishing new supplier standards for Medicare providers of orthotics and prosthetics.
CMS has announced it is convening a Special Needs Plan Chronic Condition Panel to determine the conditions that meet the definition of severe or disabling chronic conditions under MIPPA. CMS will accept comments until October 8, 2008 on the criteria the panel could use for selecting conditions. CMS held a special open door forum to discuss the Panel on September 10, 2008; an audio recording of the event will be available for 30 days beginning September 17.
CMS has posted the fiscal year 2010 Medicare inpatient prospective payment system (IPPS) new technology application on its website. The deadline for FY 2010 applications is November 17, 2008.
CMS has announced the names of 32 registries that have been qualified by CMS to submit quality data on behalf of their participants for the 2008 Physician Quality Reporting Initiative (PQRI) registry submission option.
CMS has released the “Innovator’s Guide to Navigating CMS,” which compiles key Medicare coverage, coding, and payment information in a single source. Other background information also is posted at the CMS web site.
On August 20, 2008, CMS announced that it is updating the data available on the Hospital Compare consumer Web site to include a pneumonia mortality measure, children’s asthma care measures, and data on each hospital’s risk-standardized mortality rate.
CMS has released the 2009 Part D national average monthly bid amount, the Medicare Part D base beneficiary premium, the Part D regional low-income premium subsidy amounts, and the Medicare Advantage regional benchmarks. In addition, CMS has issued guidance to clarify its “best available evidence” (BAE) policy, which requires Part D drug plan sponsors to establish the appropriate cost-sharing for low-income beneficiaries when presented with evidence that the beneficiary's information is not accurate.
CMS is soliciting comments regarding whether the agency should undertake Medicare national coverage determinations (NCDs) regarding a wide range of medical technologies. CMS will accept comments until September 28, 2008, on whether a review should or should not proceed prior to the formal decision to open an NCD, based on: 1) a significant number of inquiries from the public, providers, or patients; 2) new evidence or a reexamination of previously available evidence; 3) inconsistent or conflicting local coverage policies; 4) program integrity concerns; 5) substantial clinical advances; 6) technologies for which rapid diffusion could have a significant programmatic impact; or 7) significant uncertainty about the health benefit, patient selection, or appropriate facility and staffing requirements for a new technology. The specific technologies under review are as follows: thrombopoiesis stimulating agents, erythropoiesis stimulating agents, levocarnitine, parenteral iron supplementation, bisphosphonates, gene expression profiling tests, treatment of wet AMD, proton beam therapy for prostate cancer, artificial cervical discs, minimally invasive methods for bariatric surgery, biological therapies for treatment of chronic wounds, bone morphogenetic protein, hip resurfacing, ablation for atrial fibrillation, off label use of drug eluting coronary stents, vertebroplasty and kyphoplasty, lumbar fusion for degenerative disc disease, peripheral arterial stenting and vascular intervention, and pharmacogenomic testing.
CMS has posted the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) Medicare Evidentiary Priorities list, which lists research topics on clinical practice for which there are significant knowledge gaps. CMS encourages researchers to consider these research priorities when designing studies for items or services that have a direct impact on the health of the elderly. CMS is working with the Agency for Healthcare Research and Quality (AHRQ) to develop a process for future revisions to the priority list. CMS is accepting comments on both the Medicare Evidentiary Priorities List and a process for revising the list, although no comment deadline is provided.
On August 8, 2008, CMS announced a pilot program that will test options for Medicare beneficiaries in Arizona and Utah to maintain their health records electronically using one of several commercial personal health record (PHR) tools beginning in January 2009. Medicare will transfer up to two years of the individual’s claims data into the individual’s PHR. CMS has released a solicitation to potential PHR vendors to participate.
When MIPPA was enacted July 15, 2008, it included a number of retroactive Medicare policy provisions. CMS has begun providing guidance on implementation of these provisions, including the positive update in the physician fee schedule, the reinstatement of the therapy cap exception process, and the ability of all suppliers to furnish items in the first round DMEPOS competitive bidding areas (CBAs) at fee schedule rates. Likewise, CMS has announced that as a result of MIPPA enactment, the special accreditation deadlines previously established for the second round of the DMEPOS competitive bidding program have been cancelled, although the September 30, 2009 deadline for accreditation of all DMEPOS suppliers still is in effect.